BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCE DVC

    MDR report key: 9152289 · Received October 3, 2019

    Report

    Report Number
    1000113657-2019-10030
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    September 4, 2019
    Report Date
    October 24, 2019
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LANCING DEVICE WAS NOT RETURNED FOR EVALUATION. PACKAGING EVALUATION WAS COMPLETED: NO ABNORMALITIES OBSERVED. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-9: USER ERROR CAUSED OR CONTRIBUTED TO THE EVENT. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED REPLACEMENT PRODUCT RESOLVED INITIAL CONCERN.

    Additional Manufacturer Narrative · 1

    PACKAGING INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT THAT THE LANCING DEVICE WAS MISSING FROM THE KIT. CUSTOMER STATES THAT SHE HAD TWO CLEAR CAPS BUT NO LANCING DEVICE. CUSTOMER STATED THAT THE PACKAGE WAS GLUED SHUT BUT THAT THERE WAS NO LANCING DEVICE IN THE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947219 LANCE DVC SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC TRUEDRAW BOXED LANCINGDEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1